Lean Validation (Process, System, Cleaning, Equipment)

Computer Systems Validation

Computer Systems Validation

Independent Solutions provide full System Life-Cycle (SLC) validation for computer systems ranging from small systems to large-scale (Enterprise Resource Planning) systems in accordance with site requirements, GAMP, FDA & EU standards. This involves the development & execution (where applicable) of the following documentation:

  • Regulatory Assessment
  • Project Scope
  • Validation Project Plan (VPP)
  • User Requirements Specification (URS)
  • Functional Specification (FS)
  • Functional Design Specification (FDS)
  • Hardware Design Specification (HDS)
  • Configuration Specifications (CS)
  • Risk Assessments
  • Part 11 Compliance Assessment
  • Factory Acceptance Test (FAT)
  • Site Acceptance Test (SAT)
  • Supplier Auditing
  • Installation Qualification (IQ) protocols and Reports
  • Operational Qualification (OQ) protocols and Reports
  • Performance Qualification (PQ) protocols and Reports
  • Performance Monitoring Protocol
  • Requirements Traceability Matrix (RTM)
  • Validation Summary Report
  • Computer Systems Decommissioning
  • SOP development
  • Disaster Recovery Plan
  • Business Continuity Plan
  • Periodic Review
  • Training Plans

Examples of Computer System Validation:

Chromatography Systems, Labeling Systems, ERP Systems, Laboratory Systems & Calibration Systems.